Condition category
Skin and Connective Tissue Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
05/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dermatologyutrecht.nl/

Contact information

Type

Scientific

Primary contact

Dr M S de Bruin-Weller

ORCID ID

Contact details

University Medical Center Utrecht
Department of Dermatology
HPN G02 124
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509111
m.s.debruin-weller@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14196

Study information

Scientific title

Acronym

Effect of Myfortic® on UV-induced DNA-damage and atopic status

Study hypothesis

Our hypothesis is that in patients with atopic dermatitis which use topical tacrolimus 0.1% the repair of DeoxyriboNucleic Acid (DNA)-damage in the skin is delayed. The repair of DNA-damage in the skin of patients with atopic dermatitis which use a class II corticosteroid is not delayed.

Ethics approval

Not provided at time of registration

Study design

Clinical Trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Atopic dermatitis

Intervention

Ten patients in total with atopic dermatitis are to be included in the study. The inclusion takes place after the physician has indicated that treatment with oral immunosuppressive drugs is necessary. The informed consent intake will be performed by the researcher. At inclusion a screening will be done to evaluate the severity of the eczema and the atopic state (total and specific Immunoglobulin E [IgE], skin-prick test and atopy patch test) of the patient.

Subsequently we will compare UV-irradiated, non-lesional skin prior to treatment (control) to UV-irradiated, non-lesional skin treated with Myfortic® during 12 weeks (intervention). The Minimal Erythema Dose (MED) will be determined prior to actual irradiation. Punch biopsies will be taken immediately after irradiation with two MED and after 24 hours. A reference biopsy will be taken from skin that is not irrradiated. The whole process will be repeated after 12 weeks of treatment.

To evaluate the atopic status after 12 weeks of treatment, we will repeat the skin-prick test and atopy patch test. The final clinical evaluation of therapy will be performed after 16 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Myfortic®

Primary outcome measures

The difference between the percentage in repair of Cyclobutane Pyrimidine Dimers (CPD's) before and after treatment with Myfortic® is the primary study outcome.

Secondary outcome measures

1. The atopic state before and after treatment with Myfortic®.
2. The evaluation of the efficacy of initial high dosing with Myfortic® in order to induce rapid improvement of the disease.

Overall trial start date

01/10/2006

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age from 18 years
2. Atopic dermatitis according to the criteria of Hanifin and Rajka
3. Insufficient response to topical therapy alone
4. The physician estimates that treatment with oral immunosuppressive agents is indicated

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10

Participant exclusion criteria

1. Patients with any known hypersensitivity to mycofenolic acid or other components of the formulation
2. Oral immunosuppressive treatment in the last six weeks
3. Concomitant Ultraviolet (UV) therapy or UV therapy in the last two months
4. Contact with UV on the lesional skin for the last two months
5. Patients with thrombocytopenia (less than 75,000/mm^3), with an absolute neutrophil count less than 1,500/mm^3 and/or leukocytopenia (less than 2,500/mm^3) and/or haemoglobin less than 6.0 g/dl prior to enrolment
6. Patients who have received an investigational drug within two weeks prior to screening
7. Patients with a history of malignancy within the last five years
8. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
9. Patients with an immunologic disorder (like Rheumatoid Arthritis [RA], Systemic Lupus Erythematosus [SLE] or M. SjÖgren) or a pre-existent dermatologic disorder that worsens in combination with UV (like LE or photosensitive eczema)
10. Presence of clinically significant infection requiring continued therapy, severe diarrhoea or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study

Recruitment start date

01/10/2006

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Dermatology and Allergology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Novartis Pharma B.V.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes